Nichi-Iko Completes Biosimilar Production Facility for Japanese, U.S. Markets - Big Molecule Watch

Last week, Japan-based Nichi-Iko Pharmaceutical Co. announced the completion of a biologics production facility in Osong, South Korea by its Korean affiliate Aprogen Biologics “[t]o provide a stable supply of premium quality biosimilars to market in the USA as well as Japan.”  The facility will reportedly use a perfusion system for cell culturing, which Nichi-Iko states “features a more than a ten-fold improvement in production efficiency compared to the fed-batch culture systems used by other companies.”

According to the press release, Nichi-Iko’s first biosimilar product, an infliximab biosimilar, “was launched on November 29, 2017 in Japan, and currently is in Phase III clinical trial in the USA.” This past September, the company stated that these clinical trials, named “RADIANCE,” were “being conducted in accordance with protocols that can substantiate interchangeability.”  The company also indicated last year that it is targeting an aBLA submission in 2019 and FDA approval in 2021, and that marketing in the U.S. is to be conducted by its U.S. subsidiary, Sagent Pharmaceuticals.

Nichi-Iko’s press release further indicates that it “is proceeding with development in Japan, America and Europe, with global phase III clinical trials” of a trastuzumab biosimilar candidate.

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